YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 563 drug applications between 25 December 2025 and 31 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 95 drug names.

2025/12/25 – 2025/12/31

Period
2025/12/25 to 2025/12/31, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
563
Drugs with new generic filings (by drug name, de-duplicated)
95
Accepted this week, now under review
153

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

563filings, 147 of them generic

By application type

Application typeFilings
Supplement221
Generic147
New drug144
Import26
Import re-registration16
Unspecified9

By drug type

Drug typeFilings
Chemical drug364
TCM107
Therapeutic biologic83
Prophylactic biologic5
Biologic3
In vitro diagnostic reagent1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

95 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

320 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized23210
2AstraZeneca AB960
3Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized820
4medac Gesellschaft für klinische Spezialpr?parate mbH810
5Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized660
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
7Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized550
8Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized550
9Novartis Pharma AG540
10Hunan Jiudian Pharmaceutical Co., Ltd541

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

215 this week

AcceptedDrugApplicants
2025/12/31Import · Class 2.2 Nipocalimab注射液 · No verified English nameJXSL2500251 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/12/31Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500406 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/12/31Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500405 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/12/31Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500404 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/31Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500403 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/31Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500402 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/31Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500401 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/31Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500400 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/12/31Import · Class 1 PF-08049820水合物片 · No verified English nameJXHL2500399 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2025/12/31Import · Class 1 NIO752注射液 · No verified English nameJXHL2500398 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/12/31Generic · Class 3 Ferrous Succinate TabletsCYHS2504518 Shanxi Bao Tai Pharma Co., Ltd. romanized
2025/12/31Generic · Class 3 Cilnidipine TabletsCYHS2504509 Beijing Foyou Pharma CO.,LTD
2025/12/31Generic · Class 3 Calcium Dobesilate TabletsCYHS2504508 Beijing Kang Er Fu Pharma Co., Ltd. romanized; Ningxia Kang Ya Pharma Co., Ltd. romanized
2025/12/31Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2504506 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2025/12/31Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2504505 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2025/12/31Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2504499 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/12/31Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2504498 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Jiangxi Ke Lun Pharma Co., Ltd. romanized
2025/12/31Generic · Class 3 Lanthanum Carbonate Hydrate GranulesCYHS2504497 Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized
2025/12/31New drug · Class 1 KN5501细胞注射液 · No verified English nameCXSL2501183 Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 KN5501细胞注射液 · No verified English nameCXSL2501182 Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 KN5501细胞注射液 · No verified English nameCXSL2501181 Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 SND002细胞注射液 · No verified English nameCXSL2501177 Guizhou Sheng Nuo Bio Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 LBP-ShC4 · No verified English nameCXSL2501176 Shanghai Jun Ji Health Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 LBP-ShC4 · No verified English nameCXSL2501175 Shanghai Jun Ji Health Technology Co., Ltd. romanized
2025/12/31New drug · Class 1 注射用ALK202 · No verified English nameCXSL2501174 Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized
2025/12/31New drug · Class 1 注射用XNW28012 · No verified English nameCXSL2501173 Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized
2025/12/31New drug · Class 1 CG105 CAR-T细胞注射液 · No verified English nameCXSL2501172 Sai Si Er Qing Bio Technology (Shanghai) Co., Ltd. romanized
2025/12/31New drug · Class 1 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501171 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2025/12/31New drug · Class 1 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501170 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2025/12/31New drug · Class 1 ICG318 CAR-T细胞注射液 · No verified English nameCXSL2501168 Hangzhou Ai Sai Mian Yi Bio Medical Co., Ltd. romanized

185 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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